Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
- Conditions
- Primary Biliary Cirrhosis
- Interventions
- Registration Number
- NCT01857284
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA, and has been approved by state food and drug administration in China for treatment of cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- written informed consent
- aged 18-70 years
- increase in alkaline phosphatase for 2 folds or more
- positive anti-mitochondrial antibody (AMA) with presence of antibodies against the pyruvate dehydrogenase complex (AMA-M2)；AMA-negative patients should be diagnosed as PBC with histologic evidence.
- patients who had been treated with UDCA, immunosuppressive medications within 3 months.
- patients who had evidence of extrahepatic biliary obstruction
- patients coinfection with HBV or HCV
- patients with one of the followings: 1) hemoglobin(HB): <11 g/dl in male, <10 g/dl in female 2) white blood cell count <3000/mm3 3) neutrophile granulocyte <1500/mm3 4) platelet <50000/mm3; 5) serum albumin <3.3 g/dl 6) alanine aminotransferase(ALT)≥10×ULN and/or aspartate aminotransferase(ALT)≥10×ULN; 7) ALT≥5×ULN and/or AST≥5×ULN coexisting with immunoglobulin G (IgG) ≥2×ULN; 8) total bilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10) creatinine ≥4×ULN.
- patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.)
- definitely diagnosed as hepatocellular carcinoma(HCC), probable HCC, AFP>100ng/ml.Patients with AFP>2×ULN while <100ng/ml should re-test 2 weeks later.
- Body Mass Index >28 kg/m2
- drug or alcohol abuse.
- patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor
- patient had or on the scheduled of organ transplantation;
- patient for whom the follow-up is considered impossible
- pregnant or nursing woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Ursodeoxycholic Acid Capsules Ursodeoxycholate acid capsules, 250mg,tid, Group 1 Tauroursodeoxycholic Acid Capsules Tauroursodeoxycholic Acid Capsules,250mg,tid.
- Primary Outcome Measures
Name Time Method The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA 12 months
- Secondary Outcome Measures
Name Time Method ALP decline from baseline after 24 weeks treatment of TUDCA 12 month Total bilirubin decline from baseline after 24 weeks treatment of TUDCA 12 months GGT decline from baseline after 24 weeks treatment of TUDCA 12 months ALT and AST decline from baseline after 24 weeks treatment of TUDCA 12 months
Trial Locations
- Locations (25)
Beijing Youan Hospital
🇨🇳Beijing, Beijing, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
First Affiliated Hospital of Zhejiang University
🇨🇳Zhejiang, Zhejiang, China
Beijing 302 Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Tongji Hospital
🇨🇳Wuhan, Hunan, China
Peiking University First Hosptial
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Third Affiliated Hospital,SunYat-Sen University
🇨🇳Guangzhou, Guangdong, China
85 Military Hospital
🇨🇳Shanghai, Shanghai, China
Huashan Hospital
🇨🇳Shanghai, Shanghai, China
RenJi Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital
🇨🇳Chengdu, Sichuan, China
First Affiliated Hospital Of KunMing Medical College
🇨🇳Kunming, Yunnan, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China
Xijing Hospital
🇨🇳Xian, Shanxi, China
Shanghai Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
RuiJin Hospital
🇨🇳Shanghai, Shanghai, China
ShangHai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
The Sixth People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital,SunYat-Sen University
🇨🇳Guangzhou, Guangdong, China
Beijing Ditan Hospital
🇨🇳Beijing, Beijing, China
NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Eastern Hepatobiliary Surgery Hospital
🇨🇳Shanghai, Shanghai, China